Senior Clinical Trial Project Manager MD (m,f,d | 80-100%)

Senior Clinical Trial Project Manager MD (m/f/d | 80-100%)

In this client-facing consulting role, as part of the clinical team you will take full responsibility for the set-up and operational management of clinical investigations on behalf of our clients in the medical device and IVD sectors.

At regenold, we work in a client-focused environment that is dynamic and responsibility-driven.

If you are someone who enjoys taking ownership, guiding and advising clients with confidence and managing projects independently, this role is for you.

If you prefer purely procedural or methodical work, this role may not be for you.

Your main tasks

• Take responsibility for the set-up and operational delivery of clinical investigations for regenold clients in the medical device and IVD field
• Select, qualify, and oversee CROs and other external vendors, including feasibility, budget negotiations, contracting and performance management
• Provide sponsor oversight activities to ensure study quality, compliance and timely execution
• Prepare and submit Clinical Trial Applications and manage requests and deficiency communications
• Drive cross-functional stakeholder communication and ensure effective study governance structures
• Manage clinical investigations end to end, from study planning to close-out
• Review key study documentation, including CRO monitoring outputs and deviations, ensuring documentation quality throughout the project

Required qualifications and experience

• CRA background preferred
• 6+ years of hands-on experience in managing clinical trials with solid experience in clinical investigations
• IVD experience is beneficial but not essential
• Proven track record in senior roles such as (Senior) Clinical Project Manager / Lead, ideally across different settings (Pharma, CRO)
• Strong experience in sponsor oversight and vendor management
• Profound knowledge of GCP and the clinical regulatory environment
• Excellent written and verbal communication skills in German and English
• Strong organizational skills, with the ability to prioritize, multi-task, communicate effectively and deliver under pressure
• Degree in Life Sciences or equivalent

Benefits

• International diversity – the team and the projects
• Long-term prospects – professional and personal development, including tailored training opportunities from onboarding
• Flexibility, freedom and personal responsibility – flat hierarchies, short decision-making processes and family-friendly working time models
• Attractive salary, company pension scheme, capital-forming benefits, JobRad, Hansefit, shuttle transfer Freiburg-Badenweiler and more